Photography: Dr. Nico Symma
During the International Congress on Natural Products Research in Krakow, Poland, a Workshop “Real-world data to document the use of phytopharmaceuticals in children“ took place on 14 July 2024. The workshop was organized by the GA Foundation Plants for Health (GA PfH), the Society for Medicinal Plant and Natural Product Research (GA) and the German Society of Phytotherapy (GPT), in cooperation with several other societies e.g. ESCOP, and chaired by Prof. Dr. Rudi Bauer, GA PfH. The aim of the meeting with stakeholders from academia, industry and regulatory authorities was to develop ideas to advance the use of real world data/real world evidence (RWD/RWE) to support a more extensive use of herbal medicinal products in children and adolescents.
From a paediatrician’s viewpont, Univ.-Doz. Mag. pharm. DDr. med. Ulrike Kastner, Austria, highlighted the discrepancy between an urgent need of herbal medicinal products for paediatric patients and the availability of products that can be prescribed without off-label use. Angela Müller, Chair of the AESGP Committee Herbal Medicinal Products, presented considerations on essential requirements and framework conditions of RWD on herbal medicinal products and suggested a potential approach to best capture OTC Real-World-Data. Dr. Jacqueline Wiesner from the German BfArM stated that RWD can make important contribution to the assessment of safety and efficacy and complement other sources such as clinical trials, a big challenge, however, being the balance between quality and design of RWD and their appropriateness for regulatory decision making. From the viewpoint of the Herbal Medicinal Product Committee (HMPC) of the European Medicines Agency (EMA), Dr. Emiel Van Galen mentioned that RWD/RWD could get relevance for well-established and traditional use monographs and guidance documents, provided that the herbal substance/product as well the question to be examined are clearly defined. The general discussion elucidated the need to produce respective data that can ascertain a safe and evidence-based use of herbal medicinal products in children, an issue that is not easy to solve, particularly in the field of non-prescription products. Nonetheless, as an option for concrete actions, the conduction of a product-specific pilot study according to priorities to be considered by stakeholders could serve as a first step.
Barbara Steinhoff, 5 August 2024